BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GNS II CON INS SZ 3-4 18MM

    MDR report key: 4152766 · Received October 8, 2014

    Report

    Report Number
    1020279-2014-00625
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 2, 2014
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    PMA / PMN Number
    K951987
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

    CUSTOMER INDICATED THAT THERE IS NO PRODUCT/DEVICE TO BE RETURNED FOR INVESTIGATION ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION/LUXATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630546 GNS II CON INS SZ 3-4 18MM KNEE IMPLANT JWH SMITH & NEPHEW, INC. 10LM07117

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention